A Study of Mepolizumab as add on therapy in severe asthma
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe eosinophilic asthma on markers of asthma control (200862)
IRAS ID
164329
Contact name
Ian Pavord
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2014-002513-27
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Severe asthma can be treated using high dose inhaled steroids and controller medicines. Despite this however, severe asthma remains difficult to control. The key goal in managing control is to improve symptoms. Due to the nature of the condition, there are several measures of control that are important in managing severe asthma.
This study, funded by GlaxoSmithKline, will test the affects of a new medicine called mepolizumab on severe asthma control by measuring a participant’s health related quality of life, lung function and physical activity.
Mepolizumab is a monoclonal antibody, not yet approved for doctors to prescribe. Antibodies are molecules in blood and tissue fluids that help fight infection. Mepolizumab attaches to a naturally occurring body protein called ‘Interleukin 5’ and stops it from working. It is thought that this may help reduce severe asthma flare ups.
This study will compare mepolizumab and placebo (a medicine that looks like the study medicine but doesn’t contain the actual medicine), given by injection once monthly to participants with severe asthma who will continue taking their normal asthma medication throughout the study. One group of participants will receive Mepolizumab the other group will receive placebo. These groups will be chosen randomly by a computer.
There may be 10 visits to attend during which various tests, questionnaires and lung tests will be carried out. Every 4 weeks after the run in visit and until week 20, participants will receive one injection under the skin of the upper arm or thigh on 6 occasions.
Participants who complete this study will have participated in this study for 36 weeks. This will include a screening visit, 24 week treatment visit and a follow up visit.
At the end of the study, eligible participants may be able to continue to receive treatment with mepolizumab.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1200
Date of REC Opinion
19 Nov 2014
REC opinion
Further Information Favourable Opinion